About the Company
Thermo Fisher Scientific Inc. is the world leader in serving science, with annual revenue exceeding $40 billion. Our mission is to enable our customers to make the world healthier, cleaner and safer. Whether our customers are accelerating life sciences research, solving complex analytical challenges, improving patient diagnostics and therapies, or increasing laboratory productivity, we are here to support them. Our global team of more than 100,000 colleagues delivers an unrivaled combination of innovative technologies, purchasing convenience and pharmaceutical services.
Job Description
Are you passionate about the intersection of science and healthcare? Thermo Fisher Scientific is seeking a highly motivated and detail-oriented Clinical Trials & Regulatory Affairs Intern to join our dynamic team in Worcester, MA. This entry-level internship offers an unparalleled opportunity to gain hands-on experience in the critical fields of clinical research operations and regulatory compliance within a leading Contract Research Organization (CRO) environment. You will work alongside experienced professionals, contributing to real-world projects and learning the essential frameworks that govern the development and approval of new medical treatments and technologies. This role is designed for individuals with little to no prior experience, providing comprehensive training and mentorship to kickstart your career in clinical research.
Key Responsibilities
- Assist in the preparation, review, and maintenance of essential clinical trial documents, including study protocols, informed consent forms, and regulatory submissions.
- Support the regulatory affairs team in compiling and submitting documentation to health authorities (e.g., FDA, IRB/EC) and ensuring compliance with local and international regulations.
- Conduct research on current regulatory guidelines, industry best practices, and therapeutic area requirements to support ongoing projects.
- Help organize and maintain study files, trial master files (TMF), and regulatory archives, ensuring accuracy and completeness.
- Participate in team meetings and contribute to discussions regarding study progress, regulatory strategies, and operational challenges.
- Assist with data entry and quality control activities related to clinical trial data management.
- Collaborate with various internal departments, including project management, data management, and quality assurance, to support overall study execution.
Required Skills
- Currently enrolled in or recently graduated from a Bachelor's or Master's degree program in Life Sciences, Biotechnology, Pharmacy, Public Health, Pre-Med, or a related field.
- Strong interest in clinical research, regulatory affairs, and the pharmaceutical/biotechnology industry.
- Excellent organizational skills and meticulous attention to detail.
- Proficient written and verbal communication skills.
- Ability to work effectively both independently and as part of a team.
- Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint).
- Eagerness to learn and adapt to new concepts and procedures.
Preferred Qualifications
- Basic understanding of clinical trial phases (I, II, III, IV) and GCP principles.
- Familiarity with medical terminology.
- Previous experience in a laboratory or research setting (academic or professional).
Perks & Benefits
- Mentorship from experienced clinical research and regulatory professionals.
- Exposure to a global leader in scientific research and product development.
- Hands-on experience in real-world clinical trials and regulatory processes.
- Opportunities for professional networking and career development.
- Flexible work schedule to accommodate academic commitments (if applicable).
- Potential for future full-time employment opportunities upon successful completion of the internship.
How to Apply
If you are interested in this position, please click the "Apply Now" button below. To ensure your application is properly considered, please prepare the following:
- An up-to-date Resume or CV
- A brief cover letter summarizing your experience and motivation
Applications are reviewed on a rolling basis. Only shortlisted candidates will be contacted for an interview.
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